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All-in-one Software Solution and Expert Consulting for Medical Device and Drug Combination Product Design Controls, Risk Management, Cybersecurity, and Safety Assurance Cases
QMSpace™ Design Controls: All in One Solution for Design Controls
- Intuitive compliance with standards and regulations (e.g. CFR 820.30, ISO 13485 and other FDA requirements)
- Built in best practice based templates that Intuitively facilitate the flow down, traceability, impact analysis among design input, risk analysis, deign out, design verification, design validation, design transfer, control strategy, CAPA and post market complaint handling throughout the entire product life cycle
- Built in best practice based templates for creating and maintaining Design History File deliverables (plans, reports, review memos etc.) and SOPs for Design Controls
- Rich online editors (narrative, tabular, graphic), fully compatible with Microsoft Word, Microsoft Excel, Adobe PDF, Web browser HTML for interfacing with other electronic systems
- Configurable workflow to support team collaboration, change management , review/approval with part 11 compliant electronic records and signatures
- Built in project management tool for DHF deliverable tasks, schedule, interdependencies
- Intuitive solutions for managing platforms, variants, reuse, standardization, and library
- Automatic linking to production management, risk management, cybersecurity and safety
assurance cases
- Rich APIs for connectivity with other electronic systems
QMSpace™ Risk Management: All in One Global Risk Management Solution
- All in one Electronic Risk Management File in compliance with standards and regulations (e.g. ISO 14971, ISO 13485 and FDA requirements)
- Support multiple risks (safety, performance, cybersecurity, business etc.) and multiple sets (for different business units, product lines etc.)
- Highly configurable Templates for Hazard Analysis / Risk Assessment, Failure Mode and Effects Analysis (dFMEA, uFMEA and pFMEA) with results automatically linked
- Built-in toolkit for Fault Tree Analysis (FTA) with reliability calculation and automatic linking with the risk analysis results
- Multi Analytical Reports - Risk Heat Map, Interaction Maps, Checklists etc.
- Part 11 Compliant Electronic records and signatures
- Rich APIs for connectivity with other requirement management tools
QMSpace™ Cybersecurity: All in One Global Cybersecurity Risk Management Solution
- All in one Electronic Cybersecurity Risk Management File in compliance with standards and regulations
- Highly configurable Templates for Asset Profiling, Threat Modeling / Attack Tree Analysis, Vulnerability Analysis, Security Control Measures, Cybersecurity Risk Assessment and Summary etc.
- Automatic connectivity with Safety Risk Management
- Multi Analytical Reports - Risk Heat Map, Standard based Checklists etc.
- Part 11 Compliant Electronic records and signatures
- Life Cycle Cybersecurity Risk Management
QMSpace™ Assurance Cases: All in One Assurance Case Development Solution
- Tabular, graphic, and narractive safety assurance case editors
- Able to convert the tabular or XML format safety assurance case into graphic HTML file that can be viewed and navigated using a web browser
- Able to convert existing risk management information into a safety assurance case table or graphic
- Integration of risk management and safety assurance case throughout the product life cycle
- Intuitively guiding for additional information that is needed for a robust safety assurance case
- Electronic submission of safety assurance cases to the FDA
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